Pfizer Excludes EU Biosimilar Experience From US Epoetin Application
Even though US product has same cell line and drug product formulation as EU-approved Retacrit, Hospira subsidiary did not bridge to it in its US biosimilar application, meaning US FDA could not consider EU safety and efficacy experience.
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US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.
US FDA will hold its first-ever half-day panel review for a biosimilar; Hopsira's epoetin, which references Amgen's Epogen, has no clinically meaningful differences despite clinical trial conduct issues and PK/PD uncertainty, agency concludes.
Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.